Savara Inc. (NASDAQ:SVRA) Q4 2019 Earnings Conference Call - Final Transcript

more carefully to see if there is some pattern that isn't obvious in the averages. And this is what we mean when we say that we'll be still evaluating the outcomes more and putting back together eventually with the ENCORE data as well.

And then, comment on exacerbations in the NTM study and per and the extent to which we may offset on the benefit.

So this would fall into the same category of patient anecdotes, so -- like it's very difficult in this type of a study to make a judgment as to like are we reducing exacerbation rates when we have in our control group. But that said, like I spoke about the other types of clinical outcomes, we will be looking into some cases, where perhaps regardless of the microbiology there might still be some suppression of infection and there could be some impact on exacerbation frequency. So that's definitely possible.

Got it. Thanks very much.

Thank you.

[Operator Instructions] Our next question will come from Suji Jeong of Jefferies. Please go ahead.

Hi. This is Suji. Thanks for taking my question. So I have a question about the AeroVanc Phase 3 trial. You said you're going to enroll about 140 patients for the primary analysis group instead of 150 originally planned. So I was wondering if they would impact the powering assumption.

Well, obviously any adjustment of sample size downwards has some effect. In this case, it is a few percent point, so it is not a very big impact.

Okay. And then, my second question is on the IMPALA, the second IMPALA study. Could you guys comment on the interactions with the EMA so far?

On the second IMPALA study, our initial interaction will be with the FDA. And through that interaction, we would like to come up with a design that is agreeable with the FDA. And then, we will consider to discuss that with the EMA.

Okay. That's good to know. And my last question is the number of deaths that you saw in the OPTIMA study. So I was just wondering if that 3 deaths that you saw, is that similar to -- is that what you would have expected, given the severity of the disease?

Yeah. I mean, obviously, small study, so the numbers just reflect the severity. We have often old subjects who have chronic disease and advanced disease as well. So there is not much more to it.

I see. All right. Great. Thank you.

Ladies and gentlemen, this will conclude our question-and-answer session. At this time, I'd like to turn the conference back over to Rob Neville for closing remarks.

And actually we got one question over e-mail, so I'll just read it out. Have you seen the coronavirus impacting your business at all? And if so, what are you doing about it?

Thank you for that question. The exact impact of the outbreak obviously is a concern. We're doing all the necessary precautions from a company standpoint.